MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 LEFT; KNEE FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0005L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.The patient had a primary knee on (b)(6) 2015.The patient came in due to signs of infection, and the surgeon performed a poly swap on (b)(6) 2016.The pathology results were negative.In (b)(6) 2017 the patient came in due to signs of infection.Batch reviews performed on 04 september 2017.Lot 146800: (b)(4) items manufactured and released on 22 october 2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere tibial tray fixed cemented size 5 left, code 02.07.1205l, lot.152817 (k090988) (b)(4) items manufactured and released on 21 august 2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere tibial insert fixed flex size 5/13 mm left, code 02.12.0513fl, lot.141423 (k140826) (b)(4) items manufactured and released on 08 may 2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of infection.The pathogen is confirmed as (b)(6).The surgeon removed all medacta hardware and implanted an antibiotic spacer.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 LEFT
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6844647
• Report Number: 3005180920-2017-00489
• Device Sequence Number: 60782
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 02.12.0005L
• Device Lot Number: 146800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR